Welcome to Medical News Today

Healthline Media, Inc. would like to process and share personal data (e.g., mobile ad id) and data about your use of our site (e.g., content interests) with our third party partners (see a current list) using cookies and similar automatic collection tools in order to a) personalize content and/or offers on our site or other sites, b) communicate with you upon request, and/or c) for additional reasons upon notice and, when applicable, with your consent.

Healthline Media, Inc. is based in and operates this site from the United States. Any data you provide will be primarily stored and processed in the United States, pursuant to the laws of the United States, which may provide lesser privacy protections than European Economic Area countries.

By clicking “accept” below, you acknowledge and grant your consent for these activities unless and until you withdraw your consent using our rights request form. Learn more in our Privacy Policy.

Please accept our privacy terms

We use cookies and similar technologies to improve your browsing experience, personalize content and offers, show targeted ads, analyze traffic, and better understand you. We may share your information with third-party partners for marketing purposes. To learn more and make choices about data use, visit our Advertising Policy and Privacy Policy. By clicking “Accept and Continue” below, (1) you consent to these activities unless and until you withdraw your consent using our rights request form, and (2) you consent to allow your data to be transferred, processed, and stored in the United States.

Avastin Not Suitable For Breast Cancer Says FDA Panel

A panel of experts that advises the US Food and Drug Administration (FDA) concluded on Wednesday that the cancer drug
Avastin, generic name bevacizumab, is not a suitable treatment for breast cancer and recommended the FDA withdraw its
approval of the drug for such use. The FDA does not have to follow the recommendations of its advisory committees, but it
usually does. The agency's Commissioner Margaret Hamburg will make the final decision, although they have not said when that
will be.

The public hearing received two days of testimony from breast cancer patients, doctors and advocacy groups. Some of the
patients who spoke gave tearful accounts of their experiences, saying they were living proof that the drug works and asked for it
to be kept on the market.

But the 6 voting members of the 7 member panel voted unanimously for the withdrawal of Avastin's approval as a suitable
treatment for breast cancer, saying studies have failed to show Avastin is effective for such.

Although they acknowledged that emotions were high, the panel said they had to go with the science. Their patient
representative, Natalie Compagni-Portis, said: "I think we all wanted Avastin to succeed," but the studies "didn't bear out that
hope," reports the Los Angeles Times.

This was the second time the same panel, the FDA's Oncologic Drugs Advisory Committee (ODAC) has come to the conclusion
that the agency should withdraw its approval of Avastin (bevacizumab) in combination with paclitaxel chemotherapy for
previously untreated (first-line) HER2-negative metastatic breast cancer.

The last time was less than 12 months ago, but the drug maker, Genentech, a member of the Roche Group, took the unusual step
of filing an appeal, and lobbied the agency and Congress for a second hearing, reports the Boston Globe.

Avastin received FDA endorsement under an "accelerated approval" program that was set up in 1992 so that patients could have
access to new promising treatments more quickly. The condition was that the drug maker continue to carry out research on the
drug's safety and effectiveness.

A spokeswoman for the FDA's Center for Drug Evaluation and Research (CDER), Erica Jefferson, told CNN that since 2005,
four cancer drugs approved under the "accelerated" program have been withdrawn by the companies who make them. In all four
cases, the drug companies accepted evidence that promising early results from trials did not bear fruit in the long run.

Avastin works by starving tumors of their blood supply. It was first approved as a cancer drug in 2004, and received accelerated
approval in 2008 for use in patients with previously untreated (first-line) HER2-negative metastatic breast cancer, in
combination with copaclitaxel chemotherapy. The provisional approval was granted on the strength of early trial data that
showed an increase in the length of time patients went without worsening of symptoms.

Under the conditions of accelerated approval, Genentech had to continue to research the drug's safety and effectiveness and
report the results. But the early data did not bear out in the long run: the delay in symptoms was not as good as it had appeared at
first, and the final results of the research showed no overall improvement in survival.

But some experts say that the overall data masks cases of dramatic improvement in individual patients, perhaps explaining why
some of the witnesses at the hearing were able to relate such remarkable success stories.

However, it appears that the final decision rested on the lack of evidence that the benefits outweigh the risks, and that Avastin
does not on average, appear to help patients live longer.

In the meantime Avastin plus paclitaxel is still approved in the US for women with HER2-negative metastatic breast
cancer.

Genentech said in a statement that the proceedings and the panel recommendation has "no impact" on the drug's approved used
for other types of cancer (the blockbuster drug is also approved for the treatment of colon, lung, kidney
and brain cancers), and neither does it affect the use of Avastin for metastatic breast cancer in other countries.

"We are very disappointed by the committee's recommendation," said Genentech's Dr Hal Barron, chief medical officer and head
of their Global Product Development arm, "and hope the Commissioner does not decide to remove this important medicine for
women with an incurable disease who already have too few treatment options".

2018 Healthline Media UK Ltd. All rights reserved. MNT is the registered trade mark of Healthline Media. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.